CBT — Arterial Blood Sampling Kit Class I
Classification Details
- Product Code
- CBT
- Device Class
- Class I
- Regulation Number
- 868.1100
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K071269 | smiths medical asd | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | August 1, 2007 |
| K070340 | smiths medical asd | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | March 15, 2007 |
| K955663 | utah medical products | ABC IN-LINE BLOOD SAMPLING KIT | March 17, 1997 |
| K954015 | devon industries | ABG POINT LOK NEEDLE PROTECTION DEVICE | November 20, 1995 |
| K954035 | r-group intl | ACTI-FLEX ARTERIAL EXTENSION SET | September 25, 1995 |
| K950098 | hammer-plane | NEEDLE SAFETY COVER | August 11, 1995 |
| K945719 | sherwood medical | ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM | March 16, 1995 |
| K944941 | martell medical products | PISTON SYRINGE | December 5, 1994 |
| K945485 | devon industries | ABG NEEDLE PROTECTION | November 29, 1994 |
| K940575 | sherwood medical | ASPIR-PULSE(TM) SAF-T-VENT | March 22, 1994 |
| K931873 | steven frank mercereau | VACVENT | December 30, 1993 |
| K930986 | customed | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | July 14, 1993 |
| K925453 | sherwood medical | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I | July 12, 1993 |
| K930286 | concord/portex | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | June 22, 1993 |
| K930471 | sherwood medical | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II | June 22, 1993 |
| K914778 | martech medical products | NEOLINE(TM) | September 16, 1992 |
| K912043 | concord/portex | ACCU-VENT(TM) WITH NEEDLE-PRO(TM) | July 5, 1991 |
| K905464 | angiosystems | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | May 31, 1991 |
| K902881 | migada | LAB-SITE SAFETY NEEDLE | September 26, 1990 |
| K902632 | marquest medical products | GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS | September 4, 1990 |